Actively Recruiting
Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)
Led by Sun Yat-sen University · Updated on 2026-02-12
42
Participants Needed
2
Research Sites
191 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, single-arm, multi-center, phase II clinical trial to evaluate the efficacy and safety of selinexor in combination with R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) followed by selinexor maintenance for untreated TP53-mutated diffuse large B-cell lymphoma (DLBCL) patients.
CONDITIONS
Official Title
Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects fully understand and voluntarily participate in this study and sign informed consent.
- Aged 18 to 80 years, no gender limitation.
- Histologically confirmed DLBCL with TP53 mutations (allowing transformed or concurrent indolent B-cell non-Hodgkin lymphoma).
- No prior systemic anti-lymphoma therapy; prior local radiotherapy alone is permitted.
- At least one measurable or evaluable lesion meeting Lugano 2014 lymphoma criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Expected survival of at least 3 months.
- Adequate bone marrow, liver, and kidney function.
You will not qualify if you...
- DLBCL with Hodgkin lymphoma, T-cell lymphoma, or other non-B-cell lymphoma; Richter transformation.
- DLBCL with central nervous system invasion.
- Previous treatment with XPO1 inhibitors.
- Contraindications to any drug in the combined treatment.
- Chronic active hepatitis B or active hepatitis C unless controlled with specific criteria and antiviral treatment.
- Infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome.
- Inability to swallow tablets or gastrointestinal conditions affecting drug absorption.
- Pregnant or lactating women and subjects of childbearing age unwilling to use contraception.
- Mentally ill persons or those unable to provide informed consent.
- Any condition deemed unsuitable by the investigator.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Sun yat-sen university cancer center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Q
QingQing Cai, MD. PhD.
CONTACT
Y
Yi Xia, MD. PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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